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Principal investigator is leaving the study.
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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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The investigators are studying the accuracy of Dexcom G6 continuous glucose monitors placed on babies with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit. The participants will wear the device for 10 days on their lateral thigh. Whenever blood sugars are checked by glucometer, the investigators will also record the continuous glucose monitor sugar. Additionally, if the continuous glucose monitor alarms for a low sugar or an impending low sugar, the investigators will check the blood sugar by glucometer and, if verified to be low, treat the low blood sugar accordingly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neonates with hyperinsulinism | Neonates with a diagnosis of hyperinsulinism will wear a Dexcom G6 continuous glucose monitor placed for 10 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom G6 continuous glucose monitor | Device | Dexcom G6 continuous glucose monitor to be placed on neonates with hyperinsulinism for 10 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean absolute relative difference (MARD) | Mean absolute relative difference (MARD) between Dexcom G6 glucoses and point of care blood or plasma glucoses. | Through study completion, about 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Mean absolute difference (MAD) | MAD between Dexcom G6 glucoses and the point of care blood or plasma glucoses and the percentage of Dexcom G6 glucose values within 15 mg/dL, 20 mg/dL and 30 mg/dL of point of care blood or plasma glucose values when they are <100 mg/dL. | Through study completion, about 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Neonates with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit
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| Name | Affiliation | Role |
|---|---|---|
| Erin L Okawa, MD | Memorial Health Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miller Children's Hospital | Long Beach | California | 90806 | United States |
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| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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